Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria (MIM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02614404|
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : February 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum Malaria||Drug: Imatinib combination therapy Drug: Dihydroartemisinin-piperaquine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||December 2, 2016|
|Actual Study Completion Date :||February 2, 2017|
Experimental: Imatinib combination therapy
Administration of imatinib (400 mg/day) plus dihydroartemisinin (40 mg/day) plus piperaquine (320 mg/day) to uncomplicated adult male malaria patients. Normal health parameters will be monitored continuously to evaluate safety and the decrease in peripheral blood parasitemia with time will be quantitated to assess efficacy.
Drug: Imatinib combination therapy
Imatinib plus dihydroartemisinin plus piperaquine
Active Comparator: dihydroartemisinin plus piperaquine
Administration of dihydroartemisinin (40 mg/day) plus piperaquine (320 mg/day) to uncomplicated adult male malaria patients. Normal health parameters will be monitored continuously to evaluate safety and the decrease in peripheral blood parasitemia with time will be quantitated to assess efficacy.
Standard of care
- Time to Parasite Clearance [ Time Frame: From baseline to the time point when the blood parasite count is zero (up to a maximum of 5 days) ]Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and qPCR analysis
- 28-day Cure Rate [ Time Frame: Day 28 ]28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment and no evidence of recurrent infection with the same parasite genotype after reduction of the asexual parasitemia. Follow up after treatment will only be performed in the case of complete clearance of parasites at D5 due to Imatinib treatment.
- Frequency of adverse events [ Time Frame: Within 1 week of beginning treatment with imatinib ]
Adverse events (AEs) are defined as events possibly related to the study drug as judged by physician that occur within 1 week of beginning treatment with imatinib.
- Incidence, severity, drug-relatedness, seriousness of adverse events
- Laboratory values (biochemistry and haematology)
- Vital signs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614404
|Huong Hoa, Quang Tri, Vietnam, 520000|
|Principal Investigator:||Huynh D Chien, MD, PhD||Hue University|
|Principal Investigator:||Francesco M Turrini, MD, PhD||University of Turin, Italy|
|Principal Investigator:||Philip S Low, PhD||Purdue University|